PMA P050006S040

Device: GORE HELEX SEPTAL OCCLUDER
Applicant: W. L. Gore & Associates, Inc.
PMA number: P050006
Supplement: S040
Product code: MLV
Decision date: 2014-07-02
Classification: Transcatheter Septal Occluder
Generic name: Transcatheter septal occluder
Approval order statement: IMPLEMENTATION OF AN ALTERNATE BIOBURDEN EXTRACTION METHOD AND UPDATING EXISTING DOCUMENTS TO ALLOW FOR USE OF ALTERNATIVE/ ADDITIONAL ORGANISM STRAINS AND/OR REMOVAL OFSPECIFIC MICROORGANISM STRAIN DESIGNATIONS AND UPDATED NOMENCLATURE IN ACCORDANCE WITH USP <61> AND USP <62>.

Current openFDA PMA Record#

Device: GORE HELEX SEPTAL OCCLUDER
Applicant: W. L. Gore & Associates, Inc.
PMA number: P050006
Supplement: S040
Product code: MLV
Generic name: Transcatheter septal occluder
Decision date: 2014-07-02
Decision code: OK30
Date received: 2014-06-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: IMPLEMENTATION OF AN ALTERNATE BIOBURDEN EXTRACTION METHOD AND UPDATING EXISTING DOCUMENTS TO ALLOW FOR USE OF ALTERNATIVE/ ADDITIONAL ORGANISM STRAINS AND/OR REMOVAL OFSPECIFIC MICROORGANISM STRAIN DESIGNATIONS AND UPDATED NOMENCLATURE IN ACCORDANCE WITH USP AND USP .